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Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03700216
Enrollment
201
Registered
2018-10-09
Start date
2018-10-01
Completion date
2020-09-30
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Circulation Disorder

Keywords

limb Fracture, limb blood circulation, early-warning model, Children

Brief summary

This study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. The investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.

Detailed description

The investigator will retrospect the data of operative patients with limb fracture in Pediatric Orthopedics Unit of Shanghai Xinhua Hospital in 2016 to collect the basic information about this kind of patient, including age, gender, kind of fracture, temperature and color of skin, swell, artery pulse, laboratory test indicators, method of fixation, and the usage of mannitol. Then, combining the professionals' suggestions, the investigator will use multi-factor regression to identify the independent risk factors of blood circulation disorder. According to the independent risk factors, the early-warning model of blood circulation disorder will be built, and the rating scale as well. Finally, the critical value of blood circulation disorder after limb fracture will be set by receiver operating characteristic curve.

Interventions

None listed

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

Inclusion criteria

* Age from 0 to 14 years; * Children with limb fractures diagnosed by X-ray film; * The surgical method is open reduction and wire-pin fixation or steel plate internal fixation; * Children with postoperative plaster fixation; * Children whose guardian signed informed written consent.

Exclusion criteria

* Children with nerve damage which have caused dysfunction such as sensory and motor; * Children with fracture in other parts or organic diseases.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with Limb Blood circulation disorderWithin 1 year after mannitol treatmentNumber of participants with circulatory disorders (using mannitol treatment) after limb fracture

Secondary

MeasureTime frameDescription
Number of adverse eventsWithin 1 year after mannitol treatmentThe adverse events include acute ischemic necrosis, osteofascial compartment syndrome and disability.
Blood oxygen saturation at the end of extremitiesWithin 1 year after mannitol treatmentOxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood, which can reflect the status of blood circulation. Blood oxygen saturation can be get by using percutaneous oxygen saturation monitor.

Countries

China

Contacts

Primary ContactTing Zhu, PhD
zhuting@xinhuamed.com.cn+86-18101878907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026